Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06343207 |
Other study ID # |
249637 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
November 22, 2022 |
Est. completion date |
February 2, 2023 |
Study information
Verified date |
March 2024 |
Source |
Charles University, Czech Republic |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
To examine the acute effect of percussive therapy on peak calf muscle activation during
standing heel raise in subjects with and without chronic ankle instability (CAI).
Description:
Total of 42 subjects in mean age of 23.5 ± 2.5 years participated in this research. From the
original of 44 subjects, we had to discard 2 subjects (not finishing the measurement and
extremely outlier data). The group was divided into 2 specific subcategories as follows - 21
patients with diagnosed CAI (CAI group; respectively) and the 21 of control group patients
(HEALTHY group; respectively), including people who have never injured ankles, nor the
ligaments and muscles group surrounding the ankle complex. The information and categorization
based on the injury history to specific groups was performed by verbal questioning. The
criteria for the CAI group were having had at least two ankle luxation or ankle distortions
in the last 2 years as reported by a physician. The HEALTHY group was without this diagnosis.
All the individuals involved in the testing underwent a medical examination by a sports
physician at least once in a period of one year before testing. Subjects of both genders in
both groups were then randomly divided (balanced ratio between male and female participants
was kept) into 2 subgroups based on applied PT or not as follows: CAI YES (n=10), CAI NO
(n=11), HEALTHY YES (n=10), HEALTHY NO (n=11). The probands were informed about the research
process, which they also confirmed by signing an informed consent form according to
Declaration of Helsinki. The master thesis research was approved by the ethical committee of
Faculty of Physical Education and Sport, Charles University.
Data collection of Total Travelled Way (TTW) of Centre of Pressure (COP) during static
postural stability tests was performed by pressure platform FootScan (RS Scan International,
Belgium). Pressure sensors located in the platform sense load at frequencies up to 500 Hz. In
particular, the parameter of Total Travelled Way of COP in mm (TTW) was evaluated and
analyzed the postural stability tests consisted of two bilateral and one unilateral test.
First bilateral test was Close Stand with Open Eyes (OE) in duration of 30 s. Subject was
asked to stand on pressure platform as close as possible without touching the feet, ankles,
or knees between dominant, and nondominant lower limb. Subject was asked to relax, free both
arms besides the body and to stand as stable as possible in duration 30 s, while maximally
concentrating on the sticker black point, centered, and located 1,5 m in front wall in the
height of the eye level (individually set up). Second test was Close Stand with closed Eyes
in duration of 30 s. Besides the same body and posture position, the subject was asked to
close both eyes during 30 s stand performance. Third test was unilateral stand on one lower
limb, also called Flamingo test in duration of 30 s. Subject was asked to gently bend
non-supportive lower limb into the air, approximately to 45° knee flexion. Eyes was open
during this test. This test was performed for dominant (FLDOM) and nondominant (FLNON) lower
limb separately. Dominance of the lower limb was examined and marked by verbal questioning of
lateral preference of lower limb. During flamingo tests, subjects were able to choose which
lower limb will be tested first. This was followed by 4 trials of Heel Rise test, which the
FS recorded for 6s each. Subject was in close stand (arms free and relaxed beside the body)
and by the tester command performed controlled heel rise to maximal available and comfortable
height in tempo of 2 s concentric phase, 1 second stay in transfer position, and 2 s
eccentric phase. Results of TTW in mm during each test were evaluated by FootScan software
and assigned to individual subjects' results sheet in MS Excel (Microsoft, USA).
Data collection of calve muscle activity during static and dynamic postural stability tests
was performed by surface electromyography (sEMG) by Trigno Sensors (Delsys Inc., Natick, USA)
attached to the m. gastrocnemius vastus lateralis bilaterally by experienced practitioner of
the laboratory. After subjects' explanation and agreement, the place of sensor application
was cleaned, shaved, and again cleaned with medical cleaning cloth (Medipal, Alcohol Wipes),
consequently, the sEMG sensor was attached to measurement place by original adhesive stickers
from Delsys manufacturer. sEMG activity was recorded simultaneously in all tests. Sample rate
of recorded signal was set at 2048 Hz with a 16-bit A/D resolution. Bandwidth of sEMG sensors
was high-passed (4th-order Buterworth) at 20±5 hz and low-passed (4th-order Buterworth) at
450±5 hz for further analysis. Further sEMG data analysis was performed by EMGworks Analysis
software (Delsys Inc., Natick, USA). Recorded and filtered sEMG data underwent rectification
to absolute values and enveloped by window length (root mean squared; RMS) of 200 ms. For EMG
activation normalization of DOM and NON lower limb individually, peak RMS muscle activity
during flamingo tests (for dominant and nondominant individually) was used and applied to
represent the mean RMS in percentages of sEMG activity during each test and each lower limb
(%RMSmax). Using unilateral standing on one leg (Flamingo) was preferred before maximal
voluntary contraction (MVC) tests of calf muscles, in order to avoid excessive muscle
excitation before and during static tests and before PT application.
There was a pause (1:30min) between the 1st and 2nd measurements, during which the
experimental group received triceps surae massage for 30s each. The percussive massage gun
was set at 2100bpm and the pressure on the surface was 1 bar showed by the device, as
indicated by the manufacturer.n During the massage the sEMG sensor were replaced for the
easier access to the whole muscle group. After that it was attached to the same place as it
was before. Putting it to the same spot was simplified by the fact there were visible
pressure marks. The control group laid down to the same position as the experimental one and
stayed like that for the same amount of time (1:30min). Afterwards they were tested once
again.